Dysgeusia
Conditions
Brief summary
Intervention for dysgeusia in head and neck cancer patients undergoing radiation therapy. This research proposal aims to investigate potential benefits of mBerry in improving quality of life and nutritional outcome in head and neck cancer patients' post-radiation therapy. Our hypothesis is that cancer patients undergoing radiation therapy will benefit from use of miracle berry in treatment of dysgeusia.
Detailed description
Dysgeusia, characterized by altered taste, is a common side effect of radiation used in oropharyngeal cancer treatment. Radiation affects taste buds, leading to issues like loss of appetite, malnutrition, dependence on feeding tubes, dysphagia, and impacts social and overall quality of life. Patients often report bitter, metallic or no taste with food after radiation. Miracle berries, known for interacting with sweet taste receptors, could potentially transform acidic tastes into sweet ones. The aim is to explore mBerry's potential in alleviating dysgeusia, aiding patients in achieving better nutritional status and quality of life.This study includes the use of mBerry tablets, which contain protein within the miracle berry called miraculin, for the treatment of radiation-induced dysgeusia. mBerry is not approved by the Food and Drug Administration (FDA) for the treatment of radiation-induced dysgeusia. It is being used as part of this research study to find out if mBerry tablets improve taste outcomes among head and neck cancer patients after radiation therapy.
Interventions
DIETARY_SUPPLEMENTmBerry
mBerry tablets (.4 grams), which contain protein within the miracle berry called miraculin.
OTHERNo intervention
The control group will not received intervention.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Over 18 years * Diagnosis of mandibular cancer, tonsillar cancer, and lingual cancer * Receiving primary or adjuvant radiation therapy
Exclusion criteria
* Received a total glossectomy or total laryngectomy. * Patients with allergies to peanut, latex, peach, or soy will be excluded as they are at increased risk of allergy to mBerry. * Diagnosis of diabetes as well as prediabetic patients and those that are taking Metformin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-Point Hedonic Rating Scale | Bi-weekly for 8 weeks | Taste Test Scale used to assessing liking or preference of taste of a product. Dislike Very Much: Assigned a value of 1, this represents strong disliking. Dislike Slightly: Assigned a value of 2, indicating mild disliking. Neither Like nor Dislike: Assigned a value of 3, representing a neutral response. Like Slightly: Assigned a value of 4, indicating mild liking. Like Very Much: Assigned a value of 5, representing strong liking. The higher the number scored indicates the participants enjoyed the taste vs the lower the number participant liked the taste less. |
| Chemotherapy-induced Taste Alteration Scale (CITAS) | Bi-weekly for 8 weeks | Perceived taste scale- Self- administered questionnaire of 18 items evaluated on a five-point. Using a Likert scale 1-5 (where 1 = no difficulty or absence of the disturbance and 5 = maximum difficulty or disturbance). Higher scores indicate more severe taste alterations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| M.D. Anderson Dysphagia Inventory (MDADI) | Bi-weekly for 8 weeks | Patient questionaire on swallow function. Scored on a scale score from 0 to 100. Lower the scores indicate a greater impact of dysphagia on the patients quality of life. |
| Functional Oral Intake Scale (FOIS) | Bi-weekly for 8 weeks | Level of least restrictive diet- the higher the number the participant is able to eat by mouth the lesser of number the patient might be reliable on a feeding tube |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients weight measurement | Patients will be seen for 4 follow-up appointments in the 8 week time frame of the study. The patient will be weighed at the 1st and 4th follow-up visit. | Weight |
Countries
United States
Outcome results
None listed